BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2840679 · Received November 20, 2012

    Report

    Report Number
    1056128-2012-00135
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 25, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. A VISUAL EXAMINATION OF THE DEVICE REVEALED BIOLOGICAL MATERIAL FROM USE ON THE DISTAL TIP AND AN INDENTION IN THE TEFLON PAD. THE SCALPEL'S ACTIVATION WAS TESTED ON A GENERATOR AND THE DEVICE PASSED INITIAL, BUTTON (EACH BUTTON WAS TESTED 10 TIMES), AND PEDAL TESTING. THE DEVICE'S ABILITY TO CUT AND COAGULATE WAS TESTED USING THE SAME GENERATOR WITH MIN AND MAX SETTINGS OF 3 AND 5 RESPECTIVELY AND LIVER AS THE TEST MEDIUM. THE DEVICE PASSED ALL CUT AND COAGULATION TESTING. CUTTING/COAGULATION EFFECTIVENESS IS RELATED TO VARIOUS FACTORS SUCH AS, BUT NOT LIMITED TO, POWER LEVEL (GENERATOR SETTINGS) AND SURGICAL TECHNIQUE. THE ULTRACISION HARMONIC SCALPEL GENERATOR 300 SYSTEM USER MANUAL STATES: "WITH ALL INSTRUMENTS EXCEPT THE BALL COAGULATOR, USE A HIGHER GENERATOR POWER LEVEL FOR GREATER TISSUE CUTTING SPEED AND A LOWER GENERATOR POWER LEVEL FOR GREATER COAGULATION." SSS INSTRUCTIONS FOR USE STATE: "USE A HIGHER POWER LEVEL FOR GREATER TISSUE CUTTING SPEED AND A LOWER POWER LEVEL FOR GREATER COAGULATION. THE AMOUNT OF ENERGY DELIVERED TO THE TISSUE PAD AND RESULTANT TISSUE EFFECTS ARE A FUNCTION OF NUMEROUS FACTORS INCLUDING POWER LEVEL, BLADE CHARACTERISTICS, GRIP FORCE, TISSUE TENSION, TISSUE TYPE, PATHOLOGY, AND SURGICAL TECHNIQUE." "TAKE CARE TO AVOID APPLICATION OF PRESSURE BETWEEN THE BLADE AND TISSUE PAD WITHOUT TISSUE IN BETWEEN THEM AS THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT. THIS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2011-00017 WHERE AN ADDITIONAL PROCEDURE HAD TO BE PERFORMED DUE TO A VESSEL NOT BEING SEALED DURING THE ORIGINAL PROCEDURE, EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE ULTRASONIC SCALPEL HAD "INTERMITTENT CUTTING AND COAGULATION." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E 1978698

    Patients

    Seq Age Sex Outcome Treatment
    1